Intermacs/Pedimacs has undergone several changes recently which will be implemented June 1, 2014. The primary change reflects the transition of Intermacs from a research registry to a Quality Improvement registry which we believe will no longer require Informed Consent. Below is a list of changes, new documents and suggestions for a smooth transition. Please contact the Intermacs Data Coordinating Center if you have any questions.
• New Protocol
The new Protocol 4.0 is to be used for both Intermacs and Pedimacs.
• Waiver of Informed Consent and Authorization
Intermacs has provided a Justification letter describing why we
believe a waiver of consent and authorization is appropriate for
• List of Changes
A list of Additions and Deletions describing the changes is available.
• Revised Data Collection Forms
New Intermacs Data Collection Forms are available. Pedimacs Data
Collection Forms will be available in July.
• New security measures
A two-factor authentication application which uses a phone or hardware
token will be used to verify the user’s identity. Instructions will be
provided to Intermacs members.
The Interagency Registry for Mechanically Assisted Circulatory Support is a North American registry established in 2005 for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. Intermacs® was established as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives in conjunction with Dr. James K. Kirklin and the University of Alabama at Birmingham.
Intermacs® is a prospective registry that collects clinical data, including follow up, essentially as it happens. Post implant follow up data is collected at 1 week, 1 month, 3 months, 6 months and every 6 months thereafter. Major outcomes after implant, e.g. death, explant, rehospitalization and adverse events, are entered as they occur and also as part of the defined follow-up scheduled intervals.
Intermacs® provides contemporary data to demonstrate the continued progress of outcomes, with additional insight into appropriate risk stratification and patient selection. Death, transplant, and explant are the major discrete endpoints recorded.
Complex endpoints that include the patient’s level of function and quality of life, critical to the evaluation of current MCSD therapy, for which improvements in both survival and function have been compelling. These indices are becoming increasingly important as the survival improves, and new devices will be compared for outcomes beyond survival.
Sponsored by The National Heart, Lung and Blood Institute (NHLI) and housed at the University of Alabama at Birmingham, Intermacs® launched June 2006 with 15 participating hospitals within the United States. The registry has quickly grown to include the majority of VAD centers in the U.S, is recognized as the Joint Commission mandated registry for all U.S. centers implanting VADS for destination therapy and now has expanded to include all interested hospitals the United States and Canada.
This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract Number HHSN268201100025C.